Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075435
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription AB No No
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription AB No No
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/08/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75435ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/30/2011 SUPPL-23 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/30/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

08/29/2011 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

05/13/2010 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

07/10/2013 SUPPL-18 Labeling

Label is not available on this site.

07/14/2009 SUPPL-13 Labeling

Label is not available on this site.

10/10/2007 SUPPL-7 Labeling

Label is not available on this site.

02/22/2007 SUPPL-5 Labeling

Label is not available on this site.

04/05/2006 SUPPL-3 Labeling

Label is not available on this site.

GABAPENTIN

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 206943 ACI HEALTHCARE LTD
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075350 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090858 ALKEM
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 078428 AMNEAL PHARMS NY
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075360 APOTEX INC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 077242 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 077261 TARO PHARM
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER PHARMS

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 206943 ACI HEALTHCARE LTD
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075350 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090858 ALKEM
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 078428 AMNEAL PHARMS NY
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075360 APOTEX INC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 077242 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 077261 TARO PHARM
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER PHARMS

CAPSULE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 206943 ACI HEALTHCARE LTD
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075350 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090858 ALKEM
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 078428 AMNEAL PHARMS NY
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075360 APOTEX INC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 077242 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 077261 TARO PHARM
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER PHARMS

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